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Control of Monitoring, Measuring, and Test

Equipment
Issue 5.0
02 Dec 2014

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Revision History
Issue Date
1.0
19Aug2008

Description of Changes
Initial issue

Prime

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Table of Contents
Revision History.............................................................................................................................2
1.0 Introduction..........................................................................................................................4
1.1 Purpose and Scope..................................................................................................................4
1.2 Responsibilities.......................................................................................................................4
2.0 Process Description..............................................................................................................6
2.1 Equipment Database...............................................................................................................6
2.2 General Regulations................................................................................................................6
2.3 User Assistance.......................................................................................................................8
2.4 Registering New Monitoring, Measuring and Test Equipment..............................................8
2.5 Monitoring, Measuring, and Test Equipment Calibration......................................................9
2.6 When Test Equipment is Found to be Out of Tolerance.......................................................10
2.7 Monitoring, Measuring and Test Equipment Requiring Repair and Return.........................10
2.8 Equipment at Subcontract Manufacturers.............................................................................10
2.9 Equipment Status and associated requirements:...................................................................11
2.9.1 Equipment that is Active................................................................................................11
2.9.2 Equipment that is InActive.............................................................................................11
2.9.3 Equipment that is Damaged............................................................................................11
2.9.4 Equipment that has been Lost.....................................................................................11
2.9.5 Equipment that has been Sold/Destroyed...................................................................12
Appendix A: References..............................................................................................................13
Appendix B: Glossary of Terms and Abbreviations.................................................................14
Appendix C: Database Definitions for Cal Type...................................................................16
Appendix D: Example of an Equipment Record......................................................................17

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1.0 Introduction
1.1 Purpose and Scope
Ensure that all test and measurement equipment used in formal measurements to regulatory,
industry, or customer standards of parts, products, and systems is controlled and calibrated, or
otherwise verified, to assure product performance and quality system compliance. This document
applies to all test and measurement equipment used in the formal measurements of parts,
products, and systems. This excludes equipment used for reference purposes or not directly
involved in determining performance requirements. Labs outside the US may have procedures that
are equivalent to this procedure. They may be in the local language and address local
governmental requirements.

1.2 Responsibilities
The Calibration/Equipment Prime (hereafter Prime) at each respective location is
responsible for ensuring all MM&T equipment deployed at or from his location is properly
maintained. This includes tracking the equipment and facilitating required commercial calibration
and repair of the equipment.
1.1.1.
Tracking test and measurement equipment calibration and actions related to
calibration.
1.1.2.

Shipping or delivering test and measurement equipment.

1.1.3.

Ensuring that all required records are generated and retained.

1.1.4.

Managing communications and operations with calibration vendors.

1.1.5.
Approving requests for changes to calibration intervals as per section 6.1 or
equipment status (e.g. out of service, no calibration required, inactive, or unsuitable for
use).

Engineer/Technician
1.1.6.
Verifying the calibration status of test and measurement equipment prior to
use.
1.1.7.
Notifying Lab Manager if test and measurement equipment has not been
properly labeled.
1.1.8.
Notifying Lab Manager of any change in the status of test and measurement
equipment, including the location of the equipment.

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1.1.9.
Protecting measuring and monitoring devices from damage or deterioration
while in their possession.
1.1.10.
Preventing adjustment to devices that would invalidate calibration.
1.1.11.
Ensuring that test and measurement equipment is handled, used, and stored
within the environmental limits as specified by the manufacturer or in a manner that
would generally be considered industry acceptable.
1.1.12.
Reporting any concerns regarding the validity of a measurement made by
calibrated equipment to the Prime.
1.1.13.
Notifying the Prime when they find calibrated equipment with a past due
date.
1.1.14.
Notifying the Prime should they discover a tamper evident seal on a
measuring device that appears to be compromised.

Equipment Calibration Coordinator


The equipment calibration coordinator may be the lab manager or a designee of the lab
managers department or business unit. Responsibilities include:
1.1.15.
Initiating blanket vendor purchase requisitions with -Home-approved
calibration vendors.
1.1.16.
Coordination of calibration activities between facilities management, security,
Engineer/Technicians, administrative personnel, and the calibration vendor.
1.1.17.
Making arrangements with qualified calibration vendors, including purchase
orders, communication methods, pickup/delivery/on-site methods, and reporting
methods (certifications).
1.1.18.
Ensuring that all calibration or verification is performed against measurement
standards traceable to national or international standards (such as NIST). Where no
such standards exist the basis used for calibration or verification shall be recorded.
1.1.19.
Requesting notification from the calibration vendor when any test and
measurement equipment is found to be out of tolerance at the time of calibration. The
notice will include the nature of the deviation (the specification and whether high, low,
non-linear, etc.). This information shall be forwarded to the appropriate Prime.
1.1.20.
Ensuring that calibration vendors provide records and certificates (either
hard copy or electronic) of test results and status.
1.1.21.
Ensuring that calibration vendors protect test and measurement equipment
from damage or deterioration while in their possession, in particular when transporting
devices to and from .

will follow the ISO 9001:2008 and TL 9000 standards in controlling MM&T equipment by
selecting vendors that calibrate in accordance with measurement standards traceable to international
or national measurement standards. Such standards include:
US facilities: MIL STD 45662A, US10012-1 or ANSI/NCSL Z540 or ISO/IEC 17025

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2.0 Process Description


The control of MM&T equipment processes are described in the following sections.

2.1 Equipment Database

All Inspection, Measurement, and Test (IM&T) equipment is listed in the Equipment
Database (hereafter database) including many instruments and other devices that do not
require calibration. MM&T equipment the focus of this procedure is a subset of IM&T
equipment. This database is a web application that is accessible by all employees, using the
following link: http://intranet.i.com/apps/equipment

Every item listed in the database has its own Equipment Record that contains the details
of that unit as applicable including: identification (TAG #, Finance Asset #, manufacturer,
model number, serial number, description), current calibration status (last date calibrated,
cal. cycle, next cal. due date), Site Location, and responsible site Contact Person (the
Prime). Pertinent documents are attached to the Equipment Record such as Certificates of
Calibration. Other information is recorded as appropriate in the additional fields provided.
(See Appendix D for an example of an Equipment Record.)

Primes are accorded Coordinator status in the web application and have the authority and
responsibility to create and manage Equipment Records in the database. Equipment
Records are to be updated immediately by the responsible Prime anytime an instrument is
serviced or calibrated, or there is a change in its Contact Person or Status.

When equipment is transferred from one site to another, the Equipment Record must be
updated by the receiving site cal prime. Per QMS0082 Fixed Asset Process, the site
initiating the transfer must process the Fixed Asset Transfer Form (FRM0118) including
approvals. The Fixed Asset Transfer Form should be attached to the Equipment Record.

Every equipment item in the database is associated with a Site Location which identifies
the site that is responsible for that item, not necessarily the actual location of the item.
Where the responsible site and actual location are different, the actual location will be
captured in the Physical Location or Comments field.

The Prime who is responsible for an equipment item is indicated in the Contact Person
field in the Equipment Record. If another person should be associated with that item, his
name should be added in the Physical Location or Comments field.

2.2 General Regulations


All correspondence regarding MM&T equipment must be directed to the site Prime and will include
Manufacturer, Model #, and Serial #; additionally, the TAG # or other unique ID # (if the site tracks
by these numbers).
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Prior to use, a user will verify that the test equipment has a current calibration sticker or a
Calibration Not Required (CNR) or No Calibration Required (NCR) label/tag. If a unit
is suspected to be out of calibration or in need of repair, the calibration prime will be
notified and the equipment labeled accordingly using a visual indicator (Repair Required
tag, red tag, alert sticker, etc.) obtained from the sites Prime. Such equipment will be
removed from use.

Users will not attempt internal calibration/adjustments or repairs of equipment on


their own. Calibrated equipment will be handled and stored in a manner to maintain the
accuracy and fitness of calibration.

Calibration Intervals: Test and measurement equipment shall be calibrated at periodic


intervals as recommended by the manufacturer or as determined at the location. A test and
measurement equipment user may request a change of the devices calibration interval. The
prime will evaluate the request based on factors such as past calibration results, frequency of
use, environmental conditions, purpose, and the degree of accuracy needed.

For those cases where test and measurement equipment receive a limited calibration,
calibration cycles may be extended after careful evaluation based on factors such as past
calibration results, frequency of use, environmental conditions, purpose, and the degree of
accuracy needed.

Rental Equipment shall have a valid calibration label and calibration cert.

To maintain accuracy, all IM&T equipment must be handled and stored in such a manner as
to protect it from damage and deterioration If equipment needs to be returned to the
manufacturer or elsewhere for service or transported to another site for use there, it must be
packaged and preserved to maintain its fitness.

Certain types of test instruments employ software for conducting test measurements. When
use of such instruments is specified in feature tests, the feature test plan will identify the
requirements for the test instrument software. Prior to conducting the feature test plan, the
test engineer must verify, through the manufacturer if necessary, that the version of software
loaded on the test instrument is capable of performing the feature test. If an updated version
is required the user will download the updated version from the equipment manufacturer.
Internal software (firmware) that drives test equipment is verified during the calibration
process.

Test software used within ATS and MCS product families is generated, validated, and
maintained by SQA/Development, in accordance with QMS0014.

Test software used by ATS and MCS contract manufacturers (or internal manufacturing) is
generated, validated, and maintained in accordance with QMS0089, QMS0050, or
QMS0117.

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2.3 User Assistance


The relevant sites lab administration group or Prime will provide technical assistance and
maintenance activities for test equipment. Personnel are on site typically during daytime hours,
excluding holidays. They may also be contacted via phone call or various electronic methods such
as: email, instant message, Trouble Ticket, etc.

2.4 Registering New Monitoring, Measuring and Test Equipment


When new test equipment is received, the site Prime must be notified so as to add the
equipment to the Equipment Database. Upon receipt, the new or rented test equipment should be
checked by the Prime to ensure it is properly calibrated (if applicable) including a calibration record
and relevant sticker applied before the equipment is put into use. The Prime will also append the
Calibration Certificate to the database Equipment Record if applicable. IM&T equipment not
requiring calibration must have a No Calibration Required (or similar verbiage) label attached
before the equipment is put into use.
The new or rented equipment notification requires the following information:

Manufacturer

Asset ID# & TAG #**

Calibration Date**

Model #

Description

Serial #

Department / Location
Calibration Certificate**

Purchased or rented

** Where applicable

2.5 Quality Records


The Prime will maintain records demonstrating compliance with this procedure. Records shall be
retained for a minimum of 5 years from creation. Responsibilities may be delegated to
Engineers/Technicians or to administrative personnel, and include:
Equipment calibration certificates (either hard copy or electronic)

Shall contain vendor identifier, equipment I.D., last calibration date, calibration
interval or due date unless an alternant approach is used, condition of equipment
as received by calibration lab, and any parameters related to limited calibrations.

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Test Equipment Database

Shall contain equipment identifier, last calibration date, calibration interval or


due date, condition of equipment as received by calibration lab, and any
deviation from the norm.

Shall contain the current status of the equipment such as: calibrated, inactive,
limited calibration, and also the location.

2.1 Monitoring, Measuring, and Test Equipment Calibration


Calibration programs provide a regularly scheduled calibration process for MM&T equipment
which requires calibration. All such equipment in use must have a valid calibration label/sticker
attached. Calibration labels will as a minimum identify the unit to which they are applied by TAG #,
Asset #, or Serial #, and include the most recent calibration date and the next calibration due date.
Calibration type, extent, and interval for an individual piece of equipment will be determined by the
site Prime. Generally the OEMs recommendations will be followed, however alternate plans may
be chosen based on the equipments application, frequency of use, prior calibration results, trends,
and calibration expense. When a unit is relocated, the Prime is responsible for confirming that its
calibration type, extent, and interval conform to the requirements of the intended new application.
Each site Prime will periodically generate a calibration Recall List from the Equipment Database
web application and then locate the listed equipment items and process them for calibration per site
practice. Recall Lists will be generated frequently enough that equipment will be recalled in
sufficient time to not exceed the Calibration Due dates indicated for each.
MM&T Equipment calibration is typically performed by the Original Equipment Manufacturer
(OEM) or a third party calibration service. The calibration will be in accordance with standards
traceable to international or national measurement standards. The pertinent standard selection is
relative to the site location. Calibration Certificates will list the standard(s) utilized. The site
Prime will append all new calibration certificates to their respective Equipment Records in the
database. (Historical records that precede the integration of the database may be maintained in their
original formats and/or locations.)
Site-specific practices determine whether calibration is performed on-site during a scheduled
frequency visit; or instead equipment is shipped to the manufacturer/calibration service, on a pieceby-piece basis, for calibration there. Rental equipment will be returned to the rental source for
calibration activity. The Equipment Record includes a field that indicates the calibration type (or
NCR; see Appendix C).
Calibration for any piece of equipment must be completed prior to its indicated Calibration Due
date. If calibration cannot be completed before that date for any legitimate reason (e.g., removing
the equipment will interrupt a critical test that cant be rescheduled) then FRM0136 Calibration
Extension Request must be completed and approved prior to the expiration of the current
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calibration. Where multiple equipment items are due at the same time and affected by the same
delay, those items may all be listed in a single FRM0136. The manager of the department where the
equipment is in use (or their designee) must approve the extension request. It is then incumbent on
that same manager to ensure that the equipment is returned to the Prime for calibration as soon as it
is available and not later than the end of the approved extension.

2.2 When Test Equipment is Found to be Out of Tolerance


The acceptance criteria for calibrated equipment are considered to be the tolerance ranges specified
by the OEM. If a piece of test equipment is found to be out of tolerance, the Prime will advise the
manager responsible for the area where the test equipment was utilized. The manager will assess
the magnitude of the out of tolerance condition. Depending on the situation, the manager may call
for the re-measurement of previous test results which were produced with the affected piece of
equipment. However, if the affected piece of equipment was used in a process that was
subsequently followed by another process that would have performed the same measurement
utilizing a separate piece of equipment, then re-testing is not necessary. The activity will be
documented by means of FRM0137 Out of Tolerance Test Equipment: Action Report.

2.3 Monitoring, Measuring and Test Equipment Requiring Repair


and Return
Equipment users who discover equipment requiring repair will mark the defective equipment using
the visual indicator (tags, stickers) mentioned in section 2.2 including failure mode, time, date, the
users name, and if the user requests to be notified upon return of the repaired equipment. Such
information may also be provided to the Prime via email or Work Ticket format (as applicable at the
affected site).
The Prime will arrange repair of the equipment.

If the test equipment is under warranty or leased it will be returned to the manufacturer or
rental company.

If the equipment is out of warranty, it will be sent to either the manufacturer or a third party
repair facility.

The Prime will obtain necessary shipping documentation*, package the equipment in such a manner
as to properly protect it, ship it, and notate the status of the equipment (such as out for repair) in
the database Equipment Record.
* Reference QMS0034 Return to Vendor Process.

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2.4 Equipment at Subcontract Manufacturers


MM&T equipment owned or controlled by and provided to subcontract manufacturers or repair
centers for the purpose of verifying product conformance and/or servicing product will be
maintained as follows:

There will be an agreement between and the subcontractor stating that the subcontractor will
provide for the calibration of MM&T equipment located at its facility per the procedures
specified in the subcontractors Quality System (unless other arrangements have been made).

Copies of all calibration and repair records, including but not limited to certificates of
conformance, repair action reports, and traceability certificates, will be forwarded by the
subcontractor to the site Prime (responsible for the equipment deployed at the subcontractor)
who will maintain them in the Equipment Database (unless other arrangements have been
made).

Any regular audits of the subcontractor should include an audit of the subcontractor's MM&T
equipment calibration process and compliance to this section.

2.5 Equipment Status and associated requirements:


2.5.1 Equipment that is Active
Any equipment item regardless of Site Location that is actively in use, or being repaired or
calibrated for immediate return to use, will have its Status indicated as Active in its Equipment
Record. Active status will also apply for equipment items that are in temporary storage with
anticipated short-term recall to service. If the equipment item requires calibration, then it must also
be in a state of current calibration in order to be considered Active. Active status items may be
available for transfer or loan to a different site; those seeking equipment items listed as Active in the
database are encouraged to explore actual availability when the need arises.

2.5.2 Equipment that is InActive


Any equipment item regardless of Site Location that is available but not actively in use will have its
Status indicated as InActive in its Equipment Record. InActive status generally applies to any
serviceable equipment item, whether or not currently in calibration, that is relegated to storage with
an uncertain future in that site, or for which calibration is intentionally being delayed. InActive
units are likely candidates for transfer to another site to satisfy a current need in that new location.
Potential users are encouraged to explore transfer of InActive items when the need arises. InActive
items that require calibration must have their calibration status verified to be current before being
returned to Active status in any Site Location.

2.5.3 Equipment that is Damaged


Any equipment item regardless of Site Location that needs some form of repair before it can be
returned to use will have its Status indicated as Damaged in its Equipment Record. Details of the
required repairs when known should be entered in the Repair Required field in the Equipment
Record. Damaged status should also be indicated for parts units.

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2.5.4 Equipment that has been Lost


Occasionally equipment cannot be located when recalled for calibration or is otherwise being
sought. Such equipment regardless of Site Location will be handled as follows:

The site Prime will inform by e-mail or equivalent notification the manager of the Department
and/or Site where the instrument was last known to be located (and the CM or third-party
Repair Service when applicable) that the instrument is now Lost. Details will include full
identification of the equipment as per the items Equipment Record.

The Status of that equipment item will be changed to Lost in its database Equipment Record
and the date that it was determined to be missing entered into the Comments field. Such
equipment will continue to appear in Recall Lists and general equipment queries.

If the Lost equipment is subsequently found it first must be checked for current calibration (if
applicable) before being returned to use, or otherwise dispositioned. The items Equipment
Record will be changed to indicate its current Status.

Any equipment item that has been in the Lost Status for one (1) year will be removed from
company assets following standard Finance Department requirements and means. (See
QMS0082 and FRM0119.)

Once the Lost equipment item has been removed from assets, its Equipment Record Status will
be changed to Archive, after which that item will no longer appear in Recall Lists or general
equipment queries. However, the Equipment Record can always be retrieved by a TAG # or
Serial # query.

2.5.5 Equipment that has been Sold/Destroyed


Occasionally equipment is sold or otherwise dispositioned out of service. Such equipment will be
handled as follows:

The Prime will confirm that the sold or destroyed equipment item has been removed from
assets following standard Finance Department requirements and means. (See QMS0082 and
FRM0119.)

The Status of that equipment will be changed to Archive in its database Equipment Record
and the date that it was determined as such entered into the Comments field. Such equipment
will continue to appear in Recall Lists and equipment searches.

Attach the asset disposal form to the equipments database record

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Appendix A: References
QMS0082

Fixed Asset Process

FRM0119

PeopleSoft Asset Management Retirements Form

FRM0136

Calibration Extension Request

FRM0137

Out of Tolerance Test Equipment: Action Report

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Appendix B: Glossary of Terms and Abbreviations


ANSI

American National Standards Institute

Cal Type

Equipment Record entry for the method/resource used for calibration


per Appendix C

Calibration Interval

The time between calibrations as defined by the manufacturers


recommendation or as determined internally

CM

Contract Manufacturer; third-party production entity in possession of


-owned IM&T equipment.

CNR/NCR

Calibration Not Required / No Calibration Required

Contact Person

Equipment Record entry for the responsible site Calibration/Equipment


Prime

EMP

Edge Media Processing Division

Equipment Record Unique Equipment Database entry for each item that identifies the
equipment, Site Location, Contact Person, Status, and provides other
details and links to pertinent documentation / records like Calibration
Certificates and repair details.
I M&TE

Inspection, Measuring and Test Equipment

In-Warranty

Product manufactured in a period of time determined by the contract


with the customer as in warranty and repaired or replaced at no charge.

Inactive Equipment

Equipment that is not currently in use. Such equipment may need


calibration before use

MM&TE

Monitoring, Measuring and Test Equipment

NIST:

National Institute of Standards and Technology

OEM:

Original Equipment Manufacturer

Out-of-Warranty:

Product manufactured in a period of time that exceeds the contracted


warranty period with the customer and is repaired at the sales price as
determined by the contract with the customer.

Prime

aka Calibration / Equipment Prime; the person responsible for


calibration activities and managing entries for their Site Location in the
Equipment Database web application via the associated Equipment
Records.
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Recall List

A list generated from within the Equipment Database web application


for the selected Site Location, Department (as applicable), and time
horizon that identifies all equipment then due for calibration.

Repair Service

Site or third-party repair entity in possession of -owned IM&T


equipment.

RMA

Return Material Authorization

Site Location

Equipment Record entry that identifies the site that is responsible for
the equipment item regardless of its physical location

Status

Equipment Record entry for an items status, per para 2.9

TAG #

A unique identifier for each piece of equipment listed in the Equipment


Database.

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Appendix C: Database Definitions for Cal Type


Cal Type: Menu Option

Description

ONST On Site

(Default) A Third-Party service performs calibration at


the facility (most common).

MFG Manufacturer

sends the unit to the original equipment manufacturer


for calibration.

NCR No Cal Required

Any instrument or other listed item that never needs


calibration for its current use.

DPT Depot

Any instrument that sends to a third-party service for


calibration.

INTR Internal

Any instrument that calibrates on-site using NISTtraceable standards (rare).

CCCM Cal Controlled by Contract An -owned instrument fielded at a contractors site


Manufacturer
where that contractor is responsible for the calibration.
Can be equipment used for Operations or Repair
Service.

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